Status:
RECRUITING
MISHA Post-Market Clinical Study
Lead Sponsor:
Moximed
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
Prospective evaluation of the safety and effectiveness of the MISHA Knee System. The study will collect data on the procedural and long-term adverse events, WOMAC pain and function scores, KSS satisf...
Eligibility Criteria
Inclusion
- Key
- Subjects aged 25 to 65 years at time of index procedure
- Body Mass Index (BMI) of \< 35
- Activity exacerbated knee pain isolated to the medial compartment and not global in nature
- WOMAC pain ≥ 40
- Failed non-operative OA treatment
- Key
Exclusion
- Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device
- Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)
- Ligamentous instability
- Active or recent knee infection
- Inflammatory joint disease, including sequalae of viral infections
- Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
- History of keloid, hypertrophic or contracture scaring
- Propensity for restrictive scar formation or adhesions with prior procedures
Key Trial Info
Start Date :
November 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2030
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06118892
Start Date
November 3 2023
End Date
July 30 2030
Last Update
December 4 2025
Active Locations (2)
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1
Oregon Health and Science University
Portland, Oregon, United States, 97239
2
University of Virginia
Charlottesville, Virginia, United States, 22903